Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285505
Recruitment Status : Withdrawn
First Posted : January 28, 2011
Last Update Posted : December 4, 2018
Information provided by (Responsible Party):

Brief Summary:
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.

Condition or disease Intervention/treatment Phase
Healthy Drug: alprazolam commercial sublingual formulation Drug: alprazolam test sublingual tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet
Study Start Date : April 2011
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
Active Comparator: Alprazolam commercial sublingual tablet Drug: alprazolam commercial sublingual formulation
0.5 mg tablet, single dose

Experimental: Alprazolam test sublingual tablet Drug: alprazolam test sublingual tablet
0.5 mg tablet, single dose

Primary Outcome Measures :
  1. Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC) [ Time Frame: 11 days ]
  2. Alprazolam bioavailability as assessed by peak concentration (Cmax) [ Time Frame: 11 days ]

Secondary Outcome Measures :
  1. Alprazolam time of maximum concentration (Tmax) [ Time Frame: 11 days ]
  2. Half life of alprazolam [ Time Frame: 11 days ]
  3. Clinically significant safety laboratory tests [ Time Frame: 11 days ]
  4. Clinically significant adverse events [ Time Frame: 11 days ]
  5. Clinically significant vital signs [ Time Frame: 11 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy male or female subjects
  • BMI 18 to 26.9
  • must give informed consent

Exclusion Criteria:

  • clinically significant disease
  • narrow angle glaucoma
  • positive drug screen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285505

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01285505     History of Changes
Other Study ID Numbers: A6131020
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action